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Home » Newsletters » BioWorld MedTech

BioWorld MedTech

April 13, 2022

View Archived Issues
Woman on couch using tablet

Akili study grabs attention with digital therapeutic for adults with MDD and new hire

Akili Interactive Labs Inc. has made grabbing and holding attention a distinguishing feature of its digital therapeutics and overall company strategy. Last month, it made news with its hire of gaming industry veteran Jon David as its chief product officer. Now, a study indicates a new product in development may help people with depression extend their attention span and possibly improve cognition, two common symptoms associated with the mood disorder that are not treated by most medications. Read More
Woman working at computer in laboratory

Clinisys purchases cloud-based laboratory system Apollolims

Diagnostic testing group Clinisys Inc. has acquired cloud-based laboratory operations software company Apollolims in an undisclosed deal. Headquartered in Chertsey, U.K., and Tucson, Ariz., Clinisys will expand its public health, toxicology, and molecular diagnostics offering through the acquisition. The deal builds on the company’s combination with Sunquest and Horizon announced in January. Read More
Biotech deal illustration

Seeing opportunity in autoinjectors, Halozyme to buy Antares for $960M

Drug delivery opportunities are at the heart of Halozyme Therapeutics Inc.’s nearly $1 billion acquisition of Antares Pharma Inc. The deal brings Halozyme an autoinjector platform to complement its Enhanze drug delivery technology, which is designed to reduce hours-long treatments to minutes. Read More

US FDA calls for diversity plans for drug, device trials

As part of a series of guidances addressing clinical trial diversity, the U.S. FDA issued a draft guidance April 13 focused on improving enrollment of participants from underrepresented racial and ethnic populations. Read More
Patent-wheels.png

Roche evades induced infringement hit in patent lawsuit, but direct infringement ruling stands

Acquisitions in the diagnostics space incurs some interesting liabilities, given recent case law regarding subject matter eligibility, but this is not the only trap door for the acquiring company. Roche Diagnostics Corp., of Indianapolis, managed to avoid an induced patent infringement charge by Meso Scale Diagnostics LLC in a recent hearing at the U.S. Court of Appeals for the Federal Circuit in connection with Roche’s 2007 acquisition of Bioveris Corp. Read More
Map of Europe, Medical Device Regulation (MDR) text

France and Germany warn of collapse in patient care unless MDR transition period extended

The German Medical Technology Association, BVMed, and the French medical technology industries association, SNITEM, have issued a joint warning highlighting the risk of collapse in patient care throughout the EU. Read More

FDA advises on intended use of software used for patients with intracranial occlusions

Clinicians are still at liberty to use medical products outside the labeled indication for use, but the U.S. FDA believes radiologists may be unaware of the limitations of radiological computer-aided triage and notification (CADt) software for intracranial large-vessel occlusion (LVOs). The agency advised clinicians that these programs are not intended for use as a substitute for radiologist review of images, but instead should be used only to flag suspect images as part of an effort to triage these patients. Read More

Appointments and advancements for April 13, 2022

New hires and promotions in the med-tech industry, including: Avation, Base, Biocaptiva, Catalyst, HTG, Irisvision, Nervgen, Terumo. Read More

Financings for April 13, 2022

Med-tech firms raising money in public or private financings, including: Affyxell Therapeutics, Avacta Group, Daewoong Pharmaceutical, Lyra Therapeutics, Versantis. Read More

In the clinic for April 13, 2022

Clinical updates, including trial initiations, enrollment status and data readouts and publications: Mallinckrodt, Natera. Read More

Other news to note for April 13, 2022

Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Alyve Medical, Fujifilm, NCS America, Pear Therapeutics. Read More

Regulatory actions for April 13, 2022

Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Alio. Read More

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